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| ID | Type | Description | Link |
|---|---|---|---|
| IDRCB | Other Identifier | 2018-A00150-55 |
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The overall objective is to propose a comprehensive analysis of the biological properties of the stromal vascular fraction evaluated in the SCLERADEC 2 clinical trial (n = 15 available) and preserved in the biological collection, compared to healthy donors (n = 10). This characterization will focus on the exploration of the phenotypic and functional characteristics of the main cellular subpopulations present in the stromal vascular fraction of scleroderma patients likely to be associated with a better regenerative vascular or anti-fibrotic activity of the cell therapy product.
The main objective will be to validate whether the supposed mechanism of action of this innovative therapy, in relation to the representativity of the endothelial progenitors, carrying the vascular regeneration activity, is preserved in the sclerodermic context.
A total of 30 subjects (20 systemic Scleroderma patients and 10 healthy donors) will be included.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| patients with systemic scleroderma | Use of the biological collection of the vascualire stromal fraction of the SCLERADEC 2 clinical trial. |
| |
| healthy volunteers | Recovery of a sample of adipose tissue during a liposuction operation in a context of routine cosmetic surgery. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Study of the gene expression profile | Biological | qPCR analysis |
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| Measure | Description | Time Frame |
|---|---|---|
| Study of the gene expression profile | Study of the gene expression profile by qPCR | 18 months |
| Measure | Description | Time Frame |
|---|---|---|
| Phenotypic analysis of the cells composing the stromal vascular fraction | Phenotypic analysis performed by flow cytometry after multiple immunolabelings (CD90, CD14, CD146, CD34, CD45, DRAQ5, NucBlue Fixed Cell Stain (DAPI)) performed in accordance with the recommendations of the International Society for Cellular Therapy (ISCT) and IFATS. | 18 months |
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Inclusion Criteria:
Patients with systemic scleroderma:
Healthy volunteers:
Exclusion Criteria:
Patients with systemic scleroderma:
For healthy patients and volunteers:
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Patients with systemic scleroderma included in the SCLERADEC 2 trial and healthy volunteers who use a liposuction operation for aesthetic reasons.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jérémy MAGALON | Contact | jeremy.magalon@ap-hm.fr | ||
| Alexandra GIULIANI | Contact | 04 91 38 27 47 | drci@ap-hm.fr |
| Name | Affiliation | Role |
|---|---|---|
| Jean-Olivier ARNAUD | Assistance Publique des Hopitaux de Marseille | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Direction de la Recherche Clinique et Innovation | Marseille | 13005 | France |
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| ID | Term |
|---|---|
| D012595 | Scleroderma, Systemic |
| ID | Term |
|---|---|
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012871 | Skin Diseases |
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Stromal vascular fraction obtained from adipose tissue.
| Cell culture of the stromal vascular fraction to isolate and expand two populations of interest | Mesenchymal stem cells (MSCs) obtained by culturing the total stromal vascular fraction without an immunomagnetic selection step. | 18 months |
| Cell culture of the stromal vascular fraction to isolate and expand two populations of interest | Endothelial progenitors by a magnetic immuno-separation method (CD144 microbeads kit, Mylteni biotec) for specifically isolating and expanding endothelial progenitor cells. | 18 months |